Capnography device with constant remote surveillance and notification capabilities

ABSTRACT

A capnography device including a suitable sensor to measure carbon dioxide concentration for a target patient/user is provided. Such a device utilizes at least one microprocessor (MCU) to govern overall activation and communication between the capnograph and ultimately a data center. Such a component is provided with at least one RFID tag in order to charge device and transfer data via inductive coupling and to use as device ID for data routing purposes. The MCU may thus provide pre-programmed information to determine alert levels for a target patient/user, with the utilization, additionally of a data recordation device to capture all sensor results for such a target patient/user as well. If an alert occurs, the MCU transfers of all subsequent information from the sensors to the data center. Thus, the inventive device and system provides a real-time, reliable, wireless surveillance and notification platform that has been lacking in the industry.

FIELD OF THE INVENTION

The present invention relates to a capnograph including a suitablesensor to measure carbon dioxide concentration for a target patient (orother individual). Such a device utilizes at least one microprocessor(MCU) to govern overall activation and communication between thecapnograph and ultimately a data center. Such a component is providedwith at least one RFID tag in order to charge device and transfer datavia inductive coupling and to use as a device ID for data routingpurposes. The utilization of RFID, Bluetooth, WIFI, cellular, and MCUcomponents allows for collection and transfer of reliable data. Coupledwith a multi-faceted communication system, with variable options ofutilizing an RFID reader, wi-fi, Bluetooth, cellular, and any other typewireless communication platform, the capnograph permits immediatenotifications to various entities and effective data transfer to a datacenter for eventual processing (within, as one non-limiting example, asecure cloud). The MCU may thus provide pre-programmed information todetermine alert levels for a target patient, with the utilization,additionally of a data recordation device (like an SD card, for example)to capture all sensor results for such a target patient as well. If analert occurs, the MCU triggers communication via one of the previouslynoted data transfer methods and transfers all subsequent informationfrom the sensors to the data center through any or possibly allalternative communication pathways. An inductive coupling componentwithin the connectivity base allows for both powering up andinstantaneous data transfer on demand, as well. Thus, the inventivedevice and system provides a real-time, reliable, wireless surveillanceand notification platform that has been lacking in the industry.

BACKGROUND OF THE PRIOR ART

Respiratory concerns have always been of significant interest within themedical world. Certainly, the lack of sufficient breathing capacitylends itself to various and myriad problems for patients. Whether itconcerns chronic obstructive pulmonary disease (COPD), emphysema orother lung maladies (including lung cancer and resultant issues),asthma, allergies, failures of internal respiratory cycles, or even, toa more specific level, sudden infant death syndrome and its unknowncauses, there has been a long-standing need to understand and, moreimportantly, develop proper treatment for such breathing problems. Inparticular, the ability to actually continuously and reliably monitor asubject patient's capability of expelling sufficient carbon dioxidelevels (in relation, for instance, to the amount of oxygen inhaled) toindicate appropriate respiratory levels has been a significant concern.

Capnography is considered the measurement of the level of carbon dioxide(CO₂) in relation to a patient's respiratory status. Infrared sensorshave been typically utilized for such a purpose, particular since carbondioxide absorbs infrared light particularly well. Thus, typically,capnographs measure infrared absorption within a patient's exhalationprofile to determine the rate of carbon dioxide generation and/orexpulsion as an indicator of patient ventilation and thus respiratoryeffectiveness. The information obtained from a capnographic measurementis sometimes presented as a series of waveforms representing the partialpressure of carbon dioxide in the patient's exhaled breath as a functionof time. Such a measurement is not easily rendered, however, through thestandard devices utilized today, at least in terms of definitive dataintegrity and reliability thereof. However, for monitoring purposes,capnography is considered to be a prerequisite for safe intubation andgeneral anesthesia, as well as for correct ventilation management inother areas.

Capnographs are typically utilized in conjunction with the delivery ofmedicinal gas, oxygen, for instance, to treat certain breathingdisorders. Oxygen (and like) masks are the preferred method of suchdelivery, whether to cover the subject patient's mouth or to deliverthrough cannulae within his or her nostrils, or both nose and mouth interms of coverage and delivery (and, for that matter, receipt of exhaledcarbon dioxide, as well). Such a pathway allows for inhalation andexhalation as needed for delivery of treatment (medicinal) gas andexpulsion of the resultant carbon dioxide from the patient's respiratorysystem. Whether through an all-encompassing (mouth and nose covering,for example), mouth alone, or nose alone, such a method employs fluidicgaseous transport for such a purpose.

With these types of devices, in any event, there have been implemented,as noted above, capnography devices to monitor certain gas measurementsin relation to such treatments. These prior devices are, however,limited in that they are typically provided within the gas line as arather sizeable structure and generally capture momentary, and notcontinuous, results in such a manner. Likewise, as noted herein, suchdevices are connected through expensive cables (which are susceptible tobreakage, downtime, and replacement at significant cost) that lead to amonitoring record device that itself is of significant cost and reliesupon the reliability of the worn device, the cable connector, and themachinery therein itself to provide correct readings in relation to themeasurements collected at the worn device level. Such devices, thus, ifneeded for any type of continuing monitoring purpose, must be moved withthe subject patient. These devices, requiring a directly cable-connectedmonitor is extremely limited in terms of mobility, for obvious reasons,as the monitoring record device itself weighs a number of pounds, atleast, and requires carrying if the patient requires continuousconnection thereto. Even movement from, for example, a hospital bed to arestroom requires significant and cumbersome choreography lest thesystem be disconnected and then reconnected thereafter. If the patientdesires greater mobility, or even desires the ability to utilize such adevice at his or her home, either disconnection (when such connection isparamount for monitoring purposes, of course, at least potentially) orsignificant mobility configurations and actions would be necessary. Suchis particularly necessary due to the rather delicate nature of suchmonitoring record devices; dropping such devices at any height couldcompromise if not disrupt entirely (for that matter, break) thecapabilities of the record device to the extent that it is no longeruseful and replacement (again, at significant cost) is needed. The samecould be said for the cable connection as any rigorous activityundertaken in relation to such a component could effectively compromiseits usefulness as well. And, as above, excessive costs are associatedwith such connection components if replacement is of necessity. In otherwords, then, the current state of the capnography art is limitedsignificantly to such large, cumbersome, low-mobility (if at all)devices. Coupled with the fact that such a capnograph itself istypically rather large and connected to the breathing lines themselves,the care needed to ensure such a base device does not break during anyactivities would be of vital importance, as well. There exists adefinite need to supplant such current devices, if not the entire systemitself, to allow for greater mobility of patients, at least, and topermit improved measurement results, as well. The further ability toutilize data of great integrity in relation to such capnographicmeasurements, if not in terms of continuous, reliable results, fornotification purposes as well as possible reliable predictive healthstatus modeling, would be of significant extra benefit, too.

The current state of capnography devices and methods, unfortunately, asalluded to above, leaves much to be desired, particularly in terms ofcosts, limited monitoring intervals, cumbersome requirements in terms ofpotential mobility for a patient, and, perhaps most importantly, thelack of remote capabilities and, as a result, the inability to monitormultiple users through one data center simultaneously (and, furthermore,the lack of any real-time capabilities to provide predictive modelingfor treatment potentials for such patients). In other words, the currentmethods employ capnograph devices that are provided along an oxygen lineand record, within the confines of a “box” structure that itself isconnected through at least one cable to an outside monitoring recorderfor actual review of the patient's measured levels. Such a connection ismade through a rather expensive cable (wire/cord) and the monitoringrecord device is limited to that specific patient and, perhaps moreimportantly, is provided itself within a rather large, heavy, andbreakable structure. Although such a “standard” capnography system usednowadays has some degree of reliability for monitoring purposes, itremains problematic that such a device limits the range of mobility fora patient, at least. However, another particular important issueconcerns the fact that such a current standard system also is limited toone capnograph per one monitoring device; there are no remote dataprocessing capabilities that allow for a database to handle suchcapnogram data from multiple patients simultaneously. Additionally,however, the lack of provision of such a device within a smaller,confined area, let alone through a reliable transfer protocol other thanvia a cable that may fail or at least become damaged and requirereplacing is another significant drawback of such a “typical” system.

Additionally, the current capnograph technology does not provide anybenefits that would be certainly of great interest for a potentiallyautomated and fully enclosed system. There is lacking any definitivecapability for on-line and automatic systems checks in order to ensurethe entire device is functioning properly, both in terms of actual datacapture capacity and data transfer realities. Likewise, there is nomeans provided within the state of the capnography art to accorddefinite date and time stamp data for captured and transferred datapackets; at best, such systems merely capture data on the fly and sendthe same to a cable-connected single-person data base. There is nothingwithin the prior art disclosing a multi-patient capability with fulldata integrity capture, transfer, and back up. Furthermore, the currentsystems do not lend themselves to any predictive modeling potentials,wasting an opportunity to capture certain patient vital information thatmay be utilized to establish a future estimate as to such a specificpatient's condition and suitable suggested treatment in relationthereto. In essence, the data related to the patient's respiratorylevels (capnogram and/or waveform) are not provided in a sufficientlyreliable manner and with such integrity as to permit such a predictivemodel to be established with any precision, at least not enough forrisk-taking with such an artificial intelligence platform. Thus, thereremains a noticeable need for such beneficial results within thisspecific medical realm, which the current monitoring systems are clearlylacking. The present invention provides such benefits and overcomes thedeficiencies of the state of the capnography art.

Advantages and Summary of the Invention

One significant advantage of the present inventive capnograph is thepotential for a miniature size thereof and the ability to integrate thesame within a standard gas transport line for receipt of exhaled gases.Another advantage is the ability of such a device, at whatever size, toprovide a continuous monitoring platform through cyclic acquisition ofdata allowing for the generation of specific date and time stampsrelated to system power up and data capture for reliability and securitypurposes. Another advantage is the overall capability of such a systemto provide high integrity data for predictive modeling purposes at alevel heretofore unavailable within this area. Yet another advantage isthe capability of remote data transfer from a plurality of capnographsto a single data center for analysis and compiling purposes as desired,basically providing scalability for a widespread system for constant,reliable monitoring purposes and immediate notifications if necessary(not to mention the potential to compare and consider similar patientcharacteristics and recorded results for predictive modeling purposeswithin the same data center platform, as well). Still another advantageof this system is the utilization of programmed hardware componentscoupled with RFID tags, Bluetooth, WIFI, and/or cellular components forfully integrated and safe and reliable and low power transfer ofinformation and programming of the MCU on the fly if needed. A furtheradvantage is the ability of the overall system to provide an initialalert protocol in relation to a target patient's breathing status withthe added capability of autodirection by an MCU component to generatestreaming of such patient's subsequent capnograph status through anycommunication protocol (wi-fi, Bluetooth, RFID reader, etc.) to amonitoring data center, as well as automatically communicating with thepatient, emergency responders, or physician (and others as suitableand/or as needed), simultaneously with such alarm streaming, with theadditional capability of transferring raw data from the capnographydevice to any other receiver for compilation of verified informationinto recorded waveforms pertaining to such a patient/individual'srespiration status. Yet another distinct advantage is the utilization ofa mirrored algorithm at the MCU, the connectivity base, and within thedata center to provide a mechanism for individual system componentchecks and to compile and generate a waveform in relation to the datafrom the IR sensor pertaining to voltage differentials due to CO₂ levelmeasurements wherein the MCU provides a monitoring result fornotification and alarm purposes and the data center provides an archivalresult for analysis, diagnosis, and other possible review purposes. Andyet another advantage is the ability to provide such a device as a smallprofile structure as small as a miniaturized smart sensor within aproperly aligned and configured housing to direct and capture sufficientamounts of exhaled gases from a target individual in order to provide adevice that may be employed and deployed in a noninvasive manner (forcomfort, reliability, durability, and versatility, at least) and inrelation to any environment as needed (surgical operating room, CPAPmask, SCUBA mask, vehicle driver headset, pilot headset, etc.). The MCUcomponent contained within the capnography device itself exhibits thecapability for patient/individual data and status based upon data trendswithin a single 24-hour time period secondary to data storagelimitations based upon both space and power capacity therein. Thecapnography algorithm held within the data center permits constructionof a suitable waveform from generated, stored, and transferred data fromthe device and/or connectivity base. In this manner, the data centerprovides the ability for patient data and status to be evaluated basedupon much longer time periods secondary, again, to the capacity ofmemory space and power limitations of the capnography device itself.Still a further advantage of the disclosed system is the ability toprovide a triple benefit through inductive coupling of the capnographwith a connectivity base station, wherein physical placement of thecapnograph on such a device at the connectivity base generates powersupply levels therein, simultaneously transfers rough IR sensor dataheld within a capnograph data storage chip and/or MCU, for compilationand waveform generation at the data center and other locations asneeded, and also provides programmed directions/modifications for theMCU within the capnography device to change cycle parameters for furtherdata generation and capture. Yet another advantage of the disclosedsystem is the capability to provide automated systems checks for thedevice in addition to monitoring the patient/individual's respiratorystatus, thereby allowing for a device that can be utilized in anylocation with reliable data in a continuous manner.

Accordingly, the inventive system encompasses a capnography monitoring,notification, and analysis system comprising a) a capnography devicehaving a patient (or other individual, such as, without limitation, afirefighter, airline pilot, scuba diver, etc.) exhalation capturepassage, an infrared source providing an infrared beam through saidpassage, an infrared sensor aligned opposite said infrared source todetect infrared measurements associated with carbon dioxideconcentrations within a patient's captured exhalation, a microcomputer,at least one RFID tag, an optional data storage component other thansaid microcomputer, and a communication component including a WIFIantenna, a blue-tooth antenna, and, optionally, a cellular communicator,b) an external connectivity base comprising an inductive couplingcomponent, a receiver component for reception of communicatedinformation from said capnography device, a mirrored algorithm (e.g., anexact duplicate of the device MCU algorithm), and an informationtransfer component, and c) a data center comprising a rules engine, amirrored algorithm (as above, again, an exact duplicate of the deviceMCU algorithm), and a computer processor;

wherein said capnography device, said base station, and said data centerinclude the same algorithm for compiling infrared sensor measurementsfrom said infrared sensor to generate a capnograph waveform associatedtherewith, wherein said MCU of said capnography device further includespre-set parameters associated with certain maximum and minimum carbondioxide measurement levels, inspiration length measurement durations,and expiration length durations as captured by said infrared sensor andcompiled by said algorithm in a waveform, wherein if at any time duringutilization by a patient (or other individual), said parameters areexceeded in terms of said maximum or below said minimum carbon dioxidelevels for a pre-set continuous amount of time, then said microcomputergenerates an alarm for communication with said external connectivitybase through any or all of said communication possibilities such thatsaid external reader provides immediate notification to pre-selectedparties as to the condition of said patient in relation to saidexhalation carbon dioxide measurements, wherein, upon such anotification result, said capnography device continues to capture carbondioxide exhalation measurements with transfer from said MCU innoncompiled state to at least one communication component of said atleast one RFID tag, Bluetooth antenna, WIFI antenna, and/or cellularcommunicator, for continuous transfer to either said externalconnectivity base thereafter and subsequently to said data center, or,alternatively, directly to said data center, and said MCU furthergenerates an alarm code within said algorithm therein as an indicator ofthe situation pertaining to said alarm generation, wherein said transferto said base station and/or said data center is undertaken for transferof the alarm situation whether in terms of patient/individualrespiratory status or capnography device status via compilation of saidtransferred raw data within said mirrored algorithm and verification andprocessing thereof; and

wherein said capnography device further receives power from andtransfers information directly to said external connectivity basethrough said inductive coupling component upon placement of saidcapnography device within a certain proximity thereto said externalconnectivity base; wherein said inductive coupling capability furtherprovides raw data transfer and alarm notification to said base stationupon discovery of defect within said capnography device for possibleremedy thereof.

Additionally, such an invention encompasses a device having a physicalhousing, at least one microprocessor unit including an internal clock,at least one sensor originating source component (with up to 5 per eachmicroprocessor unit present), at least one measuring sensor (with up to5 per microprocessor unit present), wherein at least one programmed MCUis present to control activation of said sensor source(s) and saidsensor(s); wherein said at least one microprocessor unit (MCU) isprogrammed with at least one algorithm to create a capnography waveformfrom data received from said at least one sensor; at least one componentto receive formatted data from the MCU and transfer received data to anexternal connectivity base and/or data center, said component beingeither i) a RFID tag to transfer such data to an external RFID readerimbedded within said connectivity base, or ii) a NFC tag and antennae totransfer such data to an external NFC reader, (if so, then such NFC tagbeing compliant with and utilizing the ISO/IEC 15693 standard); at leastone power supply; and external communication capabilities associatedwith wireless, WIFI LAN, Bluetooth, cellular, and/or RFID readerinformation transfer;

wherein said sensor source and said sensor are configured appropriatelyand aligned for emission of a beam or like result directly towards saidsensor for measurement of a subject measurable article, level,dimension, condition, and the like; wherein said microprocessor unit isconnected to said sensor to permit transmission of data from said sensorto said microprocessor unit; wherein said MCU includes a flash memorycomponent that is formatted to receive said sensor-transmitted data;wherein said MCU includes a program (such as an algorithm, as oneexample) to process said raw data from the sensor and convert the sameinto an appropriate capnography format for patient status evaluationbased upon preset limits (maximum and minimum) in order to provideparameters to trigger the alarm function; wherein said MCU includes aprogram to format said sensor transmitted data for proper transmissionvia Bluetooth, WIFI LAN, and cellular, wherein said MCU further includesa program to write sensor data onto a data storage chip built into saidcapnography device, wherein said MCU further exhibits the ability towrite said received sensor data onto said RFID tag or said NFC tag;wherein said RFID or NFC tag is programmed to receive an interrogationfrom a suitable external connectivity base device, said interrogationand programmed status permitting transfer of the data received from saidMCU to said external reader; wherein said power supply, if present,continuously provides electrical power to said sensor source, saidsensor, and, possibly, said MCU; wherein said sensor source and saidsensor are activated by said MCU, wherein said MCU thereby acts topermit transmission of power from said power supply to said source andsaid sensor; wherein said sensor generates data from the emissionleading therefrom said source to said sensor; wherein said datagenerated by said sensor automatically transmits to said MCU; whereinsaid MCU is programmed to receive said data and to deactivate saidsensor and said source at a set time interval in relation to saidinternal clock, thereby limiting the actual amount of data transmittedby and received from said sensor; wherein said MCU stores alltransferred information from said sensor within its flash memory and/orwithin said capnography device data storage chip; wherein said MCUautomatically formats and transfers all received and stored informationto said capnography device data storage chip, unless preset alarm limitsare exceeded then said MCU writes alarm code and alarm data to said RFIDor NFC tag, and further activates Bluetooth, WIFI LAN, and or cellulartransmission systems imbedded within said capnography device to achieveconnectivity through the most efficient available connection forcontinuous data streaming at that moment; wherein the presence of aviable connection immediately starts said device alarm data streamingand powers down all other methods not being utilized, and writes alarmcode to said RFID and/or NFC tag; wherein said MCU is programmed to stopreceipt of information from said sensor and power down both said sourceand said sensor in evenly timed intervals, whereupon said MCU transferssaid information to write upon said capnography device data storagechip; wherein said RFID or NFC tag sends all received information fromsaid MCU to said external connectivity base upon each data call andinductive coupling process initiated by placing said capnography devicedirectly upon said RFID reader embedded in said connectivity base;wherein said suitable external connectivity base device base stationtransfers all received information from said at least one RFID or NFCtag, or Bluetooth, WIFI LAN, or cellular transmission to said datacenter; and wherein the total size of said housing is low-profile.Additionally, the invention also encompasses a method of providingcontinuous surveillance and external notifications for a target audiencein relation to a status and condition monitored by a device, said methodincluding the steps of: providing a device (as noted above); providingan external connectivity base attuned for transmission of signals to andreceipt of data from said RFID or NFC tag and capnography deviceBluetooth, WIFI LAN, and or cellular communication components; providinga data center external to both said external connectivity device basestation and said device, said data center attuned with said externalconnectivity base device base station to receive data transmitted fromsaid external connectivity base via said RFID or NFC tag thereto, andsaid data center including at least one mirrored algorithm in relationto the algorithm present within said capnography device and/or rulesengine to analyze and act upon said received data; introducing saiddevice within a proximate distance of the item to be monitored; totransmit any data written thereon to said external connectivity base andsimultaneously causing said MCU to directly activate said electricalsignal; receiving samples for monitoring within or proximal to saiddevice wherein said activated source provides said emission to saidactivated sensor within and/or proximate thereto said monitored item ispresent and measured by said source, in relation to fluctuations ofvoltage measured thereby; transferring said captured measurement datafrom said activated sensor to said MCU, said transmission of datacausing said at least one MCU to receive said data and to subsequentlyindicate deactivation, thereby causing said source and said sensor topower down until reactivated by said MCU, wherein said MCU remainsactivated for receipt of data, but is limited to such data transmittedby said activated sensor, wherein said transmitted data is stored withinsaid flash memory of said MCU; formatting of said transmitted datastored within said flash memory to a suitable language for transmissionand writing on said RFID or NFC tag and/or said capnography device datachip; transmitting said formatted data from said at least one MCU eitherto said RFID or NFC tag or directly to said connectivity base ordirectly to said data center through wireless, Bluetooth, and/orcellular signal from said MCU; wherein if said signal (alarm code) issent through either via said RFID or NFC tag, such is communicated tosaid external connectivity base in response to a subsequent data calland upon receipt of said alarm code from either of said RFID or NFC tagto said external connectivity base without prior connectivity of any ofthe other communication avenues (wi-fi, Bluetooth, cellular, etc.), thensaid communication between said capnography device and said externalconnectivity base is undertaken by one of said other communicationavenues as is easiest to achieve (e.g., first to connect with saidexternal connectivity base in such a situation); and repeating each stepindefinitely thereafter; wherein said external connectivity basereceived data is transmitted to said external data center in relation tothe identity of the target item associated with said device and saidexternal connectivity base, wherein said external data center mayutilize such received data (such as, without limitation, as a capnogramwaveform for such a target patient) for continuous comparative review ofsaid target item's standard status for surveillance purposes, whereinany deterioration and/or degradation of such a waveform signal willfurther allow for target item owner/manufacturer/care provider, etc.,notification, emergency notification, or both, dependent upon theseverity of any detected deterioration and/or degradation.

Alternatively, the system may utilize the same basic protocol but withthe MCU programmed to continuously receive and analyze sensorinformation regarding the capnogram associated with the breathingprofile (carbon dioxide partial pressure, as indicated with microvoltagevariations within the IR sensor, as one example) of the wearing targetpatient (or individual) to compare for specific parameters. To that end,then, the MCU will include an algorithm to generate a waveform inrelation to the recorded voltage differentials provided by the IR sensorper the levels of continuously recorded carbon dioxide measurements.With an excess of carbon dioxide or a measurement below a thresholdminimum, or above a threshold maximum, for that matter, and continuingfor a set amount of time (since a brief outlying measurement may not besufficient for such an alarm protocol), the MCU will alert properindividuals and/or entities if such measurements thus indicate adistinct breathing problem or other like event associated with carbondioxide generation and expulsion during respiration. During such amonitoring operation, the IR sensor measurements are not only convertedto a waveform for alarm purposes by the MCU, but such raw data is storedwithin the capnography device data storage chip in data packetsgenerated within pre-set time intervals and pursuant to definitiveamounts of data per cycle generating such individual data packets. Asnoted herein, such data packets are thus in relation to specific timesat which each cycle begins (I1) as the IR source and sensor areactivated, at which time the IR sensor data is transferred to the MCU(D1) as well as the amount of such data transferred during such a settime duration, and which the MCU (from its cache or like saved database) transfers the data to said capnography device data storage chipand, in the case of device alarm parameters being exceeded, creation ofan alarm code (A1). The type of alarm code identified in data (A1)indicates any changes that the mirrored algorithm held at the datacenter and the external connectivity base should initiate in relation tothe overall system interval or powerup time (I1). Thus, while the MCUutilizes the same generated raw data as is stored for eventual transferand handling by the data center through a data packet interpretation andwaveform generation algorithm, the same algorithm (mirrored) presentwithin the MCU and the external connectivity base itself generates amonitoring waveform for continuous monitoring purposes. In this manner,then, the monitoring capability of the MCU solely performs such anoperation for that purpose and does not store the data or generatedwaveform. The MCU data packet handling and eventual transfer to theexternal connectivity base device base station and on to the data centerprovides a full capnogram waveform for a physician, etc., to thenutilize for patient analysis, diagnosis, and treatment purposesthereafter any such notification occurs. The resultant data centerwaveform generation thus provides a data and time stamp and overallblock chain result with regards to such data as the I1, D1, A1, and datapacket size limits all provide integrity to the type and amount of suchraw data for conversion at the data center level such that completereliability is permitted and provided in relation thereto. Furthermore,the system itself actually functions within a UDP protocol at thatpoint, with, however, a further capability of instead of moving forwardwith only data that is present and provided within and at a location forhandling at the moment of transfer (as is customary within a UDP system;if some data is missing within such typical UDP protocols, the systemmoves on and does not require for further functioning all such data),the provision of the I1, D1, A1, and data size limitations accords thesystem the ability to have all such data correlated within the datacenter (and external connectivity base) for complete compilation thereoffor, again, full data packet integrity for a true and reliable capnogramwaveform generation for physician, etc., review, at least.

Thus, if at the MCU level, and during waveform generation by thealgorithm present therein (the same algorithm that ultimately generatesthe waveform at the data center upon data transfer from the externalconnectivity base and then to the data center), a result of sufficienttime resides outside the thresholds (minimum or maximum of carbondioxide exhalation), and thus notification thereof thus occurs, theoverall system then provides such stored (recorded) data within eitherthe MCU or, for instance, a micro SD card (or like implement) presentwithin the capnography device itself to the connectivity base, throughRFID, inductive coupling through placement of the capnograph on a properdevice on (or around, perhaps) the connectivity base itself. As notedabove, this activity serves a dual purpose of such data transfer (forultimate transfer to the data center of raw data for algorithmconversion to waveform through data packet block chain operation) andpower up of the capnograph for further utilization thereafter. As well,the MCU will then, once the capnograph is returned to a propermonitoring location by the user, store and transfer subsequent sensordata within its cache for immediate transfer using the RFID tag forinductive coupling as noted above. In this manner, and dependent uponthe availability at that moment for RFID transmission to the externalconnectivity base, whether such transferred data is provided throughinterrogation and response between such external connectivity base andRFID tag or, if necessary, and as alluded to above, as well, directlyfrom said MCU to either said external connectivity base or said externaldata center through the wireless, Bluetooth, and/or cellulartransmission capabilities. Either way, and as described below in greaterdetail, such data transfer is handled reliably and with integritywithout processing until such data is properly considered in relation tothe specific parameters of data capture and storage provided within theconfiguration of RFID tag, device data storage chip, MCU, etc., of theinventive capnography device. Additionally, the data from the sensor(and thus transferred initially to the MCU) may be further transferrednot just to the base and/or data center, but also to receiving devices(such as, without limitation, smart phones, such as within at least oneapp, computers, and the like, basically any device accessible via theinternet through wifi, Bluetooth, etc., communication protocols)associated with recipients authorized for such a purpose. Thus, withoutlimitation, the individual's physician may have transferred to his orher computer device (again, smart phone, computer, etc.) such data inraw form for eventual compilation in a waveform for analysis anddiagnosis, if necessary. Thus, as with the MCU, the base, and the datacenter, such a recipient device will include the same mirrored algorithmfor such compilation purposes. Importantly, however, the algorithm inall such locations and devices is utilized primarily as a means toverify the transferred data in raw form prior to actual compilation andthus processing. As noted above, each data packet generated through theparameters of each data cycle includes an I1 value associated with theexact moment such a cycle begins, the value (D1) associated with thetransfer initiation of data from the sensor to the MCU until the MCUpowers down the device (which thus creates the cycle upon which the MCUpowers up the device as I1 and the new cycle begins with data transferfrom IR sensor to MCU as D1) at which time such data transfer ends, andthe actual size of the data transferred during such a cycle (which isconsidered a static amount in relation to such a time elapse and part ofthe D1 value). Also present is an alarm time (A1) that is provided bythe MCU once the alarm is undertaken and an alarm code is generated bythe MCU algorithm that ultimately modifies the data generation andcapture of the device thereafter to determine and verify the reason forsuch alarm generation. The alarm code generation thus causes thealgorithm (and thus MCU) to stream all further captured raw data to anexternal location including the same (mirror) algorithm, including,without limitation, and depending on pre-selected and authorized subjectrecipients, the base station, the data center, and any othercomputerized device that may receive such data via wi-fi, Bluetooth,and/or cellular communication protocol directly from said capnographydevice associated with said patient/individual. Thus, each algorithmlocation will receive the same data packets as they are generated(subsequent to an alarm, of course, which first indicates there was anexcess or lack of sufficient carbon dioxide within the patient or,again, other individual) exhalation measurements. As these data packetsare received, each value for each cycle is sought in order to permitcompilation thereof as the total amount and proper I1, D1, A1,transferred data size, and final time must meet specific expectedtargets. If such targets are not properly filled, the data is notverified for further processing, thereby allowing for the overall systemto check one device result with another for complete verification ofdata integrity before any data processing is undertaken, thus allow forprevention of any hacked material, and, perhaps more importantly,provision of data that will result in a complete and true waveform forpatient/individual health and security. Such a data integrity protocolwithin the overall capnography system provides a reliable blockchainprogram, as well, since the data involved must be verified within allalgorithm-containing devices before any processing is permitted. Thespecified data size requirement effectively prevents any inclusion ofunexpected (hacked) data or other information introduced therein. Insuch a manner, no hacking is allowed as the different devices within theoverall system will not process any raw data until such verificationsteps are completed. In this manner, then, the overall system allows fora single IR sensor to be monitored, ultimately, by any selected numberof external devices as well as the capnography device on which it ispresent, with the ability of the synched mirror algorithm within suchexternal device to verify the raw data transferred thereto from saidcapnography device as well as provide continued individual respiratorystatus and capnography device status simultaneously through systemschecks associated with such received raw data. The overall system thusprovides a unique benefit that a capnography device may be remotelycontrolled and monitored with automated systems checks to permitutilization at any location with continued monitoring and surveillance.Additionally, if the algorithm does not function properly in associationwith the MCU of the device for some reason, the MCU may then, without aninitial alarm as to carbon dioxide concentration measurements, and asanother system check capability, stream the captured raw data from theIR sensor directly to any or all remote mirrored algorithm locations inorder to provide constant monitoring and surveillance of the subjectindividual's respiration status by such remote devices (base station,data center, authorized individual recipients, etc.) with alarm code andnotification supplied in such a manner, if necessary.

As it concerns, then, capnography, such a system may include acapnography device and/or method utilizing the same, as describedgenerally below:

a capnography device comprising a three-dimensional housing, saidhousing including:

-   -   a) a hollow pass-through chamber,    -   b) at least one MCU including an internal clock and an algorithm        for translating raw data to a capnogram waveform,    -   c) at least one IR source,    -   d) at least one IR sensor,    -   e) a component to receive formatted data from the MCU and        transfer received data to an external reader, said component        being either i) a RFID tag to transfer such data to an external        RFID reader imbedded in connectivity base, or ii) a NFC tag and        antennae to transfer such data to an external NFC reader (said        NFC tag being compliant with and utilizing the ISO/IEC 15693        standard, as one possibility);    -   f) one or more communication devices for direct communication        with said external connectivity base (or possibly said external        data center), said devices selected from the group consisting of        wireless (wi-fi), Bluetooth, cellular, and any combinations        thereof;    -   g) a separate data storage device associated with an inductive        coupling component; and    -   h) at least one power supply associated with said inductive        coupling component;        -   wherein said IR source and IR sensor are configured on            opposing sides of said pass-through chamber and aligned for            emission of an IR beam directly towards said IR sensor;        -   wherein said IR source is programmed to emit an IR beam            within a range of from 4.26-4.30 micrometer frequency;        -   wherein said microprocessor unit is connected to said IR            sensor to permit transmission of data from said IR sensor to            said microprocessor unit;        -   wherein said microprocessor unit includes a flash memory            component that is formatted to receive said IR            sensor-transmitted data;        -   wherein said microprocessor unit includes a program to            format said IR-sensor transmitted data for proper            transmission to produce proper capnography waveform to and            write on capability on said RFID tag or said NFC tag, and            said device data storage chip;        -   wherein said power supply continuously provides electrical            power to said IR source, said IR sensor, and said MCU;        -   activates said IR source and said IR sensor upon activation            through said MCU, or, permit transmission of power from said            power supply to said IR source and said IR sensor;        -   wherein said IR sensor generates data from the emission beam            passing through said open chamber from said IR source;        -   wherein said data generated by said IR sensor automatically            transmits to said MCU;        -   wherein said MCU performs a regimen of activating and            deactivating said IR sensor and said IR source at a set time            interval in relation to said MCU internal clock, thereby            limiting the actual amount of data transmitted by and            received from said IR sensor within each            activation/deactivation cycle in order to thereafter and            therein permit said MCU to store all transferred information            from said IR sensor within its flash memory;        -   wherein said MCU is programmed to stop receipt of            information from said IR sensor and power down both said IR            source and said IR sensor in evenly timed intervals,            whereupon said MCU transfers said information to data            storage chip;        -   wherein said MCU is simultaneously and separately programmed            to receive said data and generate a waveform therefrom            through utilization of said algorithm, thereby allowing for            continuous comparison with specified parameters of low and            high thresholds of carbon dioxide levels for pre-set time            intervals within said waveform associated with said sensor            results, wherein if such results fall outside said            parameters, said MCU alerts proper individuals and/or            entities of such an occurrence;        -   wherein said MCU automatically formats and transfers all            received and stored information to said device data storage            chip as data packets for eventual transfer to said            connectivity base and then to said data center wherein the            same algorithm present within said MCU is utilized to            generate a waveform for archival and medical provider            viewing purposes, said transfer provided through inductive            coupling operation at the connectivity base via contact with            said capnograph;        -   wherein said RFID or NFC tag sends all received information            form said MCU to said external connectivity base upon each            interrogation and/or inductive coupling, or, if such a            communication route is not possible (for instance, the            reader is outside the range of communication with said RFID            tag), then the wireless, Bluetooth, or cellular            communication device is utilized for such a purpose;        -   wherein said suitable external connectivity base transfers            all received information from said at least one RFID or NFC            tag and/or wireless, Bluetooth, or cellular to said data            center;        -   wherein said separate storage device is programmed to            receive information transferred from said MCU and            subsequently transfer said information to said external            connectivity base through said inductive coupling component,            of which said external connectivity base includes a            complementary component such that contact therebetween            allows for such information transfer;        -   wherein said at least one power supply is replenishable            through said inductive coupling component and whereupon such            contact therebetween said inductive coupling component and            said complementary component included within said external            connectivity base device base station allows for charging of            said at least power supply; and        -   wherein the total size of said housing, within which all of            said components are attached and present, is defined by a            range of 3 to 10 millimeters wide, a range of 3 to 10            millimeters long, and from 3 to 10 millimeters deep.

As it pertains to the potentially preferred embodiment of utilizing aminiaturized smart sensor capnography chip device as the initial sensor,such may be embedded into and/or within a capture chamber ring. Such aring preferably is sized to attach to the standard end of anendotracheal tube and/or tracheostomy tube (since all these ventilationappliances have standard diameter). Such a capnography smart sensor chipincludes low energy IR source (such as, without limitation, a filamentof a quartz tungsten halogen lamp engraved into a silicon chip) with afocusing lens narrow band IR filter for 4.26 micrometer wavelength(based on the Abbe number of the glass) with an opposing IR sensitivematerial (PbS, PbSe, InSb, or CdS) fused into silica with a thinsapphire coating shield for filtering, again, as non-limiting materials.A slight curvature in the microchip along with the aforementionedfocusing lens allows for the IR beam to be directed toward the IRsensitive material embedded within the chip just under a thin layer ofsapphire. The CO₂ from the patient/individual will disperse equallythroughout the chamber ring to provide a small sampling area in themiddle thereof to derive a suitable overall CO₂ concentration as well asto then detect the changes in such a concentration based upon the targetpatient/individual's respiration levels causing the displacement of theCO₂ sample in the chamber.

The capnography (miniaturized) smart sensor chip is less than amillimeter in scale, at most 1 and preferably around from 0.01 to 0.5mm, in length, width, and depth. Such a chip should be programmed tocycle the IR source to acquire the most efficient HZ required togenerate an appropriate capnography waveform. The sensor should alsohave the programming to adjust cycles in relation to temperature andpressure and a memory cache to hold at least 30 min of raw dataacquisition.

The smart sensor capnography chip is provided with such a ring chamberthat fits easily within and is held appropriately (tightly, snugly,etc.) as needed to reside within a base housing component but may beeasily removed, if needed, without damaging the housing, chamber ring,or chip, itself. Such a housing will thus be configured to allow forsuch introduction of the chamber ring/chip component (such as a propersnap-in action with proper alignment therein) and further includes abase material that allows for sufficient retention thereof the chip andchamber ring, particularly if the chip is curved in relation to the lensportion thereof for directional capability between the IR source and IRsensor components. The base housing thus also includes the othercomponents necessary for utilization of the remote surveillance andnotification capabilities thereof, as well as communication capabilitieswith a base, data center, and/or other devices authorized to receivesuch notifications upon an alarm result in relation to thepatient/individual respiration status. Thus, included are the MCU(including the mirrored algorithm present within such othercommunication devices and locations), the power assembly to operate andactuate the IR source as needed (with the MCU including programming tocontrol such actions), the RFID tag for communication with the externalbase as well as facilitate the charging of the device via inductivecoupling, and the communication (connectivity) component for data centerand/or other device transmissions, thus including Bluetooth, Wi-Fi, andcellular antennas, etc., for such a purpose. The power assembly (source)is rechargeable in any type of suitable manner (battery, graphene, etc.)and must keep such power for IR source operation (at least) for aminimum of 26 hours with a minimum of 4 hours of data streaming as well.Additionally, the housing includes a data storage chip therein thatreceives raw data from the smart sensor chip in relation to the targetpatient/individual's respiration status (as discussed above) for accessby the MCU component for determinations of respiration status for alarmmonitoring and surveillance. Such a data chip may be of any typicalconstruction and make for such a purpose, and must also retain at least26 hours of continuously streamed raw data from the smart sensorcapnography chip. The MCU in the Housing should be able to take the rawsensor data transferred from the capnography sensor chip and create asuitable capnography waveform. All alarm parameter programming is alsoretained within the housing MCU which also directs the initiation ofdata transfer via one of the data transfer methods (Bluetooth, Wi-Fi,cellular, etc.). Additionally, the MCU also transmits the raw data todata storage chip which must hold, as noted above, at least 26 hours ofraw sensor data. The housing MCU also verifies the proper functioning ofthe sensor chip (such as the receipt of data for raw data conversion tocapnography waveform initially for alarm purposes; if the I1, A1, D1,and/or data amount values do not meet expected values, then, as notedabove, the system may determine a problem exists within the smart sensorcapnography chip). The housing MCU alarm limits must be adjustable tothe target patient/individual in terms of acceptable CO₂ levels inrelation to time as well, thus allowing for programming of the MCU forsuch a purpose. In addition, there should be alarm parameters inrelation to respiratory rate for the target patient/individual which isderived from a suitable capnography waveform.

As discussed above, an external base station is utilized in conjunctionwith this smart capnography sensor chip/housing device that provides thecharging of the housing power source through inductive coupling.Additionally, this inductive coupling capability allows for raw datatransmission (if the alarm system is activated, as noted above) andshould provide 7 days of raw data storage and contain a mirroredalgorithm or exact duplicate of the algorithm held in the housing MCU.The base station should also provide connectivity for up to 7 separatehousings or devices. The external base should provide internetconnectivity and or LAN connectivity.

The external data center, again, as noted above, will also include acomponent with the exact mirrored algorithm present within both thehousing MCU and the external base station. This will provide mobileaccess for healthcare providers and/or other monitors to view the targetpatient/individual's capnography waveform for diagnostic purposes.

Overall, then the inventive method may potentially be interpreted as: amethod of providing continuous surveillance and external notificationsfor a target patient in relation to his or her respiratory status andcondition, said method including the steps of:

-   -   i) providing said capnograph of above;    -   ii) providing an external connectivity base device base station        attuned for transmission of signals to and receipt of data from        RFID tag, NFC tag, Bluetooth, wireless, wifi lan, and/or        cellular;    -   iii) providing a data center external to both said external        connectivity base and said capnograph, said data center attuned        with said external connectivity base to receive data transmitted        from said data RFID tag, NFC tag, wireless, Bluetooth, or        cellular, and/or wifi thereto, and said external data center        including at least one mirrored algorithm and/or rules engine to        analyze and act upon said received data;    -   iv) introducing said capnograph within an oxygen delivery device        or as a standalone device, wherein said capnograph is placed in        close proximity to said target patient's mouth and/or nose to        allow for exhalation samples to pass through said chamber;    -   v) having said MCU power up said IR source and said IR sensor;    -   vi) receiving said exhalation samples within said capnograph        chamber wherein said activated IR source provides said IR beam        from one side of said chamber to said activated IR sensor on the        opposing side of said chamber, wherein said IR beam, when        powered to emit, excites molecules within said chamber present        samples at that moment in time to permit measurement of        concentration of carbon dioxide during each power up status in        relation to fluctuations of voltage measured thereby;    -   vii) transferring said captured measurement data from said        activated IR sensor to said MCU unit, said transmission of data        causing said at least one MCU to receive said data and, through        an algorithm, generate a waveform from said data to compare        continuously with set parameters of high and low thresholds for        a target patient, wherein if said carbon dioxide concentration        measurement falls below or exceeds such thresholds, then said        MCU immediately alerts said patient and any other pre-set        persons and/or entities of such an occurrence, and the also        subsequently indicates deactivation by said MCU, thereby causing        said IR source and said IR sensor to power down until        reactivated by said MCU, wherein said MCU unit remains activated        for receipt of data, but is limited to such data transmitted by        said activated IR sensor, wherein said post-alert transmitted        data is stored within said flash memory of said MCU and all data        prior to such an alert is transferred to a separate storage        device (micro SD card, for instance);    -   viii) formatting of said post-alert transmitted data stored        within said flash memory to a suitable language and/or format        for transmission via Bluetooth, wifi lan, cellular and        transmission and writing alarm code on said RFID or NFC tag; and    -   ix) repeating each step indefinitely thereafter in cycles;        -   wherein said external connectivity base received data is            transmitted to said external data center in relation to the            identity of the target patient associated with said            capnograph and said external connectivity base, wherein said            external data center may receive such stored pre-alert data            and all post-alert data is provided for continuous            comparative review of said target patient's standard            breathing for further surveillance purposes, wherein any            deterioration and/or degradation of such a waveform signal            will further allow for target patient physician,            notification, emergency notification, or both, dependent            upon the severity of any detected deterioration and/or            degradation.

The programmed MCU provides for cyclic type powering up and down of saidsystem, there is, for capnography purposes, an IR source and ajuxtaposed IR sensor as well as a battery for providing sufficient powerto such a source (other types of sensors may not require such powerlevels, but, such an IR system actually requires lower amounts of powerthan those that remain in an activated state indefinitely).

Thus, in relation to such a device the MCU, acts as a system initiator.The MCU remains dormant for data acquisition until it receives data fromthe sensor which requires activation of the system by the MCU. The MCUinternal clock is set for a cycle requirement (such as for instance, andwithout limitation, a 10 hertz cycle, or 100 microseconds) which is theprocessing time. The MCU clock starts with a “wake up” secondary toreceiving data from IR sensor and receives data from the sensor for thecycle time amount (for example, without limitation, again, 100microseconds, or a 10 hertz cycle) based on the internal clock setting.Subsequently, the MCU programmed process is initiated at the end of each(10 hertz) cycle, at which time the MCU deactivates the systemdeactivating the sensor source and sensor. Thereafter, and the secondprocess of the MCU, it transitions sensor-received data held in flashmemory therein into proper format to produce a proper capnographywaveform for evaluation purposes including potential alarm activation.Then the MCU sends the raw non-process data to the data storage chip.The MCU clears its flash memory cache and “sleeps” until said internalclock with algorithm causes the MCU to initiate system power-up and tomonitor for the receipt of data from said IR sensor. As noted above, forprocess checking purposes, the MCU should be connected to the system ina manner which allows MCU internal clock with algorithm to providesystem power-up. Also, the CPC codes for the RFID tags are also used forpatient/device/item identification utilizing a tokenization method forsecurity purposes (if needed). The external connectivity base ID is thusused to assign other information for identification purposes (such asfacility and doctor identifications for health patients, for onenon-limiting example). The RFID tag CPC codes and external connectivitybase ID codes are used together to route information and data sent fromconnectivity base to data center for routing to an appropriate mirroredalgorithm and or rules engine/machine learning AI within the database,as well. The MCU acts as the power regulator, but acts similarlyotherwise to receive data from the IR sensor and transfer data to thedevice data storage chip.

Such a system, however, potentially preferably utilizes the MCU as aninitial gatekeeper to determine threshold capnogram measured results (inan algorithm-generated waveform) from a target patient to determine ifsuch a person necessitates medical aid due to exhalation (respiratory)levels falling outside parameters over a set time interval foracceptable and/or normal considerations. Thus, although, as above, theMCU can cause the cyclical capabilities of a capnography system tomonitor, capture, and send all data continuously (in cycles) to aconnectivity base and ultimately a data center for data processing, thesystem, again, potentially preferably, functions to provide any alertsas to respiratory problems (in terms of exhalation measurements forcarbon dioxide) primarily. In such a situation, the MCU not onlyreceives all such continuously generated results, but creates acapnoform (waveform) separately from such data that allows for thecomparison capabilities for notification purposes, as noted above. Suchan operation is configured for 24-hour intervals overall to suchmonitoring purposes before power supply replenishment, and thusinductive coupling activation for such a purpose, with the simultaneoustransfer of stored raw data (the same data utilized by the MCU algorithmto generate the monitoring waveform) to the external connectivity baseand then to the mirrored algorithm in the data center for compilationand ultimate archival waveform generation. Thus, upon inductive couplingactivation to such an extent, the user then places the capnograph backto the desired location near his or her exhale stream for furtheroperations to such an extent. As noted previously, then, if at any timethe threshold measurements are outside the acceptable parameters for aset time interval in relation to the waveform generated by the MCUalgorithm, the MCU provides a protocol for immediate notification to thetarget patient, medical provider(s), and/or emergency personnel.Additionally, then, the storage to the separate storage device ends andthen the MCU undertakes the cyclical capabilities noted above toeventually write alarm code to the RFID tag and then such data istransferred, whether by interrogation and response by said RFID tag,through wi-fi, Bluetooth, and/or cellular channels, to the externalconnectivity base (dependent on which communication capability isavailable and/or most effective and/or efficient at that moment intime), which then transfers the same to the data center.

With such an overall system and capnograph device, the user has what maybe termed as a passive notification protocol to best ensure completemonitoring and notification of breathing status is provided. In thismanner, then, the user is supplied not only with a device that permitscomplete monitoring of his or her breathing status, but such alsoprovides a system that alerts if, for instance, the user falls down,passes out, or otherwise has lost any capability of actively requestinghelp or medical attention. To further such an overarching capability,the capnograph may further be supplied with an accelerometer componentto indicate if and/or when such a device is, for instance, dropped,atypically moves in one direction, or otherwise acts or is activated ina manner than is not conducive to standard wearing and utilization. Inother words, the inclusion of such an accelerometer accords a morecomplete remote presentation of the status of the device, and thusstatus of the user, for that matter, in that the potential for loss ofsensor data (or at least data recorded within set parameters associatedwith proper capnograph placement on or around the user's respiratoryexhalation stream) may be accounted for if such an accelerometer recordsan activity simultaneously with any skewed or insufficient datarecordation. In this manner, again, a more robust and/or completeexplanation of the overall patient/user breathing status is providedwith the continuous monitoring through the MCU-contained (and/orexternal connectivity base and/or external data center) algorithm and IRsensor measurements.

The overall system further includes some assumptions and standards foroperational guidelines and purposes. It is important that the MCUacquires a set amount of data packet samples (100 microseconds/10 hertzof data, for example) to allow for the exactness of time and data size(possibly) for the database to match data requirement in mirroredalgorithm in relation to such specifics. The number of cycles per minutemay be attenuated as needed throughout the system through theprogramming of device MCU algorithm and mirrored external connectivitybase and/or external data center algorithm. The RFID tag CPC code isused by the system and not in any way by the customer. An RFID tagnumber is the CPC code and cannot be read by the human eye in anymanner. The system may be supplemented by a login and password for thepatient/device/item portal and may further employ (simple) out of bandverification for safety in this manner, if necessary. Such out of bandprotocols may use open source OATHE protocols, and additionally, or insubstitution thereof, it may utilize an EMOJI device (such as driven bysystems developed by Symshield).

Such a capnography device may be provided in a miniaturized size andstate in comparison with typical capnography instruments. Such maysimply snap on/clip to an established structure (such as a CPAP mask,nasal cannula oxygen delivery device, and the like) with the componentsas presented within the drawing and described above. Additionally, sucha device may be implemented with any type of structure that allows forclose proximity to the mouth and/or nose of a subject patient (ormonitored user, if monitoring is desired due to physical situationand/or status, such as, as non-limiting examples, a truck driver, apilot, a mountain climber, a SCUBA diver, a long-distance runner orbiker, and the like); thus, again, as one example, a microphone attachedto headphones may include a snapped in device as described and disclosedherein to monitor such breathing conditions. In any event, such acapnograph fits on a patient's face with nasal prongs pointed upward andin a side slot end piece; its size is about 1.2 cm cubed is placed intoeach side with a cable coming from each cube. Such a small size device,coupled with the remote monitoring discussed herein with an externalconnectivity base and storage database accessible by such an externalconnectivity base under any standard wireless communication protocol,permits a number of beneficial results for a patient. Different optionsare mainly in the form of multi-system integrated monitoring such asperimeters for wandering patients, healthy lifestyle optimization suchas having monthly report read by a physician, and they can order thesmall component pieces of such a device easily for repair, etc., moreoften. Again, with IR sensors, at least, a certain amount of continuousbattery power is needed to account for the high requirements of such asensor and source. Thus, a graphene, lithium ion, or like, battery(compact for the small device) may be utilized having a battery life forthe capnography device of roughly 24 hours possibly more through MCUprogramming in relation to patient condition and alarm status for systempower up. The recharging procedure occurs through inductive couplingusing the reader device base station, and additionally a micro-USB plugmay be placed on the device, if necessary. It may have a USB connectionso it could charge using all the options available to cell phones orother devices including wall plug, computer, or those small deviceswhich provide remote charging capabilities. Charging may also beaccomplished while the device is actually worn, as well. The systemwould include a low battery alert which can be send to cell phone, calllandline using VOIP and we could add an indicator light to device (verysmall LED).

Alternatively, the system may include an NFC component for MCU transferand reader transmission, if desired. Such NFC components provides themobility with the tap and pair functionality out of the box. Thepatient/device/item provides a wifi or LAN ID and password so that theexternal connectivity base may work and link in as soon as it comes outof the box. The patient/device/item can then access the appropriatecommunication portal for the ability to change external connectivitybase settings remotely. Since the system does complete devicefunctionality checks continuously, if for some reason such requests aremissed, such can be handled remotely by a suitable technical team as anymissing external connectivity base data calls would require interventionto ensure the device is functioning properly. In addition, if needed,the patient/device/item would be notified to switch to NFC and cellularprotocols until the system is corrected as needed. Additionally, therecan be provided an app or like program for download to a communicationdevice (smart phone, for instance) which provides parameters that can beupdated so that the device only sends to the data center at the momentof wifi link, LAN link, or if data coming from the device falls outsideof set parameters. Such travel, mobility, and hardware factors areimportant components of the system versatility, as well.

Thus, in terms of the potentially preferred embodiment relating tocapnography, such an inventive system relates to a capnograph includinga suitable sensor to monitor (and measure) carbon dioxide concentrationand respiratory rate for a target patient. Such a device utilizes a RFIDor NFC component for recordation of alarms and Bluetooth, wifi, orcellular, and or inductive coupling transfer of capnographic informationfrom the device to an external connectivity base and ultimately on to adata center for constant monitoring and immediate notification asneeded. Such information is gathered through a repetitive infrared (4.3micrometer wavelength) source and appropriate sensor that cycle in termsof power up and down in relation to MCU algorithm programming. The IRsource and sensor are oppositely configured on sides of a breathingtunnel component within the device to permit continuous and cyclicalexcitation of present carbon dioxide ostensibly to create an initialreading for the target patient's capnogram in relation to voltagedifferences over time. The IR sensor is connected to and transferscollected data to a microprocessing (MCU) unit that stores suchinformation within its flash memory, shuts off the overall system power,formats the received and stored data, and transfers the formatted datato the capnography algorithm for interpretation and possible alarmactivation. The programming in MCU provides cyclical powering of system.The MCU triggers power down of the IR source and sensor (to preventburnout and allow for cyclical measurements) until the data acquisitiontime limit is reached as defined by MCU programming. sending data to thedevice data storage chip, and so on. Such causes immediate transfer ofall data transferred from the MCU to the device data storage chip, totransfer to the external connectivity base and on to the data center. Atthe data center, the received data is transitioned from such raw datainto a capnographic waveform through the utilization of a mirroredalgorithm and/or rules engine. In this manner, a base waveform isdeveloped for each target patient and the repetitive readings create ameans to create a standard by which all further monitored breathing (CO₂measurement and respiratory rate) for such a target patient is compared.Any degree of deterioration from the standardized measure is analyzedfor the potential for intervention with assessments for routinephysician notification up to emergency notification, all providedthrough the encompassed system itself. Thus, the capnograph deviceessentially provides the means for constant, real-time, and remotemonitoring of a target patient's CO₂ inhalation and exhalationconcentration data, respiratory rate, and consequent overall respiratorystatus with fully reliable identification of the patient, location, andtreating physician, as well as automatic notification to all necessaryparties should a compromised measurement exist at any time the device isproperly worn and utilized. Such a device allows for a number ofbeneficial results, improving the monitoring and treatment of patientshaving respiratory conditions, at least.

Patients, care givers, and medical providers can be notified immediatelywhen capnography reading falls outside of individual patient directedparameters. In addition, the system provides a mechanism for sampleacquisition interval adjustment in real time based upon need. Thisprovides both the benefit of energy savings and the ability to increaselevel of monitoring as needed. This need may be identified by one ormultiple reading outside of defined patient profile monitoringparameters or by the identification of trends noted in the patientpredictability modeling of patient health status decompensation. Thisgives the patient's healthcare provider with a more complete anddetailed report highlighting the need for possible intervention thatpatient has shown with previous health status change. The sampleacquisition interval is controlled by the increase in the Hertz cycle ofthe MCU which is in direct relation to the static MCU internalprocessing clock. Additionally, as alluded to above, the health caresupplier (physician, nurse, etc.) and/or monitor may receive such rawdata concerning the patient/individual through direct communication fromthe capnography MCU to their own device where the same algorithm aswithin the capnography MCU, the base, and the data center is present toprovide the necessary verification of each data packet supplied theretoallowing for generation of the subject patient/individual's capnographicwaveform for continuous streaming subsequent to an alarm code generationto permit monitoring thereof and, if needed, diagnosis and/ordetermination if medical attention is required and at what time. As alsoalluded to above, this overarching system thus allows for completeverification of data in every instance it is transferred prior to anyprocessing thereof, from patient to provider and elsewhere, as needed.Coupled with the alarm capabilities discussed above, the overall systemthus provides a complete and continuous surveillance and notificationprogram for any and all individuals present in a situation whereexternal exhalation measurements are of significance. Thus, thecapnography device may be included within typical oxygen, etc., tubes,clipped thereon or provided as an add-on structure to capture exhaledbreaths. Thus, the range of utilization of such a system and capnographydevice is extremely broad from typical injured persons within a hospitalsetting (such as a patient treated with certain high-powered anesthetic,to intensive care monitoring; including, without limitation, neonates),to CPAP users, to crib-based infants to monitor breathing, to airlinepilots, to scuba divers, to semi truck drivers, basically any situationthat allows for wireless monitoring and possible alarming of respirationconcerns, may be included within such end-uses.

Patient healthcare providers (or analogous devicemanufacturers/suppliers/repairpersons, etc.) will be able to request astandard capnography (or other sensor device reading, etc.) report forreading in addition to the notification in change in patient capnographydata which may include falling outside the defined parameters forpatient profile for acceptable CO₂ level or by system identifying trendnoted in patient predictability model with the data associated withsystem prediction sent to a healthcare provider and or patient. Thehealth care (or other type) provider can have secure individualconfigurable API access with multiple options for notification, reportviews, sorting, etc. In addition, medical (or like) facilities or othergroups or individuals which are identified by patient as needing accessto respiratory status capnography monitoring may also have a filteredview secure individual configurable API based upon need and patient orhealthcare provider direction.

The patient profile may also be configured to used data from othersystems such as bed alarms, perimeter alarms, or other systems toconfigure a secondary or dependent rules engine to enhance functionalityfor those such as dementia patients in relation to wondering or gettinglost using the systems indicated above. In addition, the system can sendother respiratory systems such as CPAP, Ventilator, or other oxygendelivery systems real time data regarding respiratory status fortitration, or modification of therapy parameters such as increasingFIO₂.

The capnography device may also be utilized within monitoring systemsand devices, including, without limitation, gas masks (such as toprovide protection from smoke, chemical reagents, and/or othertoxic/dangerous substances, ostensibly to allow for the user/wearer'srespiratory condition to be monitored from any location duringutilization), particulate masks, scuba systems, airplane pilot oxygenmonitors (whether passenger, delivery, fighter, etc., jet pilots),anesthetized patient monitors, and any other type of device forrespiratory monitoring purposes.

Viewing this as an analogous system in relation to anything having acontinuous monitoring capability and the need for raw data capture, butprocessing only after any determination (definitively) of the presenceof unexpected data within a transferred data packet, it should beevident that any type of measured consideration for condition and statussurveillance (and possible notification of difficulties therein) may beimplemented in the same basic fashion, particularly if remoteutilization and requisite device monitoring, in addition topatient/individual status, provides such beneficial results. Thus, theoverall inventive system and method is not to be taken in any limitedmanner or fashion with this disclosure and all due breadth and scopeshould be accorded in relation to the actualities provided herein.

Furthermore, of particularly important benefit it is noted that sincethe initial device only generates, captures, and transmits only rawdata, such an overall system provides a mechanism for multi-partydynamic encryption without increasing data packet size caused byencrypting the data itself through other standard encryptionmethodologies. Thus, since the captured and transmitted amount of rawdata from the IR sensor/smart sensor chip to the MCU of the device islimited to an exact value, the data packet sizes cannot be alteredwithout causing the system to refuse such raw data, thereby, again,providing a multi-party dynamic encryption capability for reliable datacapture and utilization.

No limitation is intended with this disclosure as to the utility andbreadth of the overall system of providing data integrity describedherein, including, without limitation, the myriad end uses andindustries such may be provided to and for and utilized within, theblock-chain capabilities such a system provides within any such industryalluded to above, the artificial intelligence capabilities such areliable data capture and transfer method provides within any industry,and any device and/or method implementing and/or employing such adisclosure provided herein.

Additionally, such an invention further encompasses the utilization of aunique combination of such device components with external conduits,gate keepers, filters, and algorithms. Thus, also encompassed herein isa method of providing continuous surveillance and external notificationsat a data center location for a target patient in relation to his or herrespiratory status and condition through a cycled process including theutilization of a capnograph as defined above, wherein said external datacenter includes i) an algorithm mirrored in relation to algorithmimbedded into device MCU to provide the exact results in relation toprocessed data in both device, external connectivity base, and externaldata center ii) a) to govern the functions of said capnograph, waveformgeneration including changes in sample acquisition interval as indicatedby alarm code b) to act as a gatekeeper for data receipt, and c) toprovide modifications to the frequency of cyclical data capture andgeneration, iii) an algorithm for processing data from data packets tocreate an exact capnography waveform to be used by medical provider forpatient status evaluation, and iv) an algorithm for processing data fromsaid external connectivity base and or device including but not limitedto an exact algorithm mirrored to precisely match algorithm held indevice MCU and said external connectivity base.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exploded perspective view of one potentially preferredcapnography device.

FIG. 2 shows a side perspective view of the capnography device of FIG.1.

FIG. 3 shows a side perspective view of a capnography device implementedwithin a CPAP mask.

FIG. 4 shows an exploded perspective view of the entire compositestructure of FIG. 3.

FIG. 5 shows a flow chart of the actions undertaken within thecapnography device in one possible embodiment of the disclosed system.

FIG. 6 shows a flow chart of the actions undertaken within the basestation device in one possible embodiment of the disclosed system.

FIG. 7 depicts a smart sensor capnography chip and ring chambercomponent as part of one potential embodiment of the inventivecapnography device and system.

FIG. 8 shows a potential housing embodiment for combination with thechamber/chip component of FIG. 7.

FIG. 9 depicts the combined chip/housing components for inclusion withina further in-line device for utilization within the overall system.

DETAILED DESCRIPTION OF THE DRAWINGS AND PREFERRED EMBODIMENTS

Reference now should be made to the drawings, presented as non-limitingpossible embodiments in accordance with the descriptions provided above.The ordinarily skilled artisan would fully understand the breadth andscope intended herein in relation to the following potentially preferredtypes.

It will be understood that, although the terms first, second, third,etc. may be used herein to describe various elements, these elementsshould not be limited by these terms. These terms are only used todistinguish one element from another element. Thus, a first elementdiscussed below could be termed a second element without departing fromthe teachings of the present disclosure.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting. As used herein, thesingular forms “a”, “an”, and “the” are intended to include the pluralforms as well, unless the context clearly indicates otherwise. It willbe further understood that the terms “comprises” and/or “comprising” or“includes” and/or “including” when used in this specification, specifythe presence of stated features, regions, integers, steps, operations,elements, and/or components, but do not preclude the presence oraddition of one or more other features, regions, integers, steps,operations, elements, components, and/or groups thereof.

FIG. 1 provides an exploded view of a potentially preferred capnographydevice (10 of FIG. 2). Shown is a top shell cover 1 to provideprotection for and over an MCU processor 2 (with, as one non-limitingexample a 433 MHz radio component for compilation and communicationpurposes). A top shell 3 provides a placement location for the processor2 within a suitably configured recess 3 a therein and connects with thetop shell cover 1 for such a benefit. A top shell mid cover 4 allows forconnection between carbon dioxide sensors 5 and the processor 2 throughchannels 4 a therein. A bottom mid shell 6 structure provides a baselocation for the carbon dioxide sensor component 5 (including aninfrared beam generator 5 a and an infrared sensor 5 b to detect carbondioxide levels) with guides 6 a for placement of such carbon dioxidesensor components 5 therein in opposite relation and attachment with thetop middle shell 4. The top middle shell 4 includes a top archway 4 band the bottom mid shell 6 includes a bottom archway 6 b in order toform, upon attachment of the two shells 4, 6 and opening (12 in FIG. 2)that provides the channel for a patient to breath into for collectionand measurement of carbon dioxide levels. A bottom shell 7 is furtherprovided to support a battery 8 (such as, without limitation, a 7-voltLiPo type, although any like rechargeable battery implement may beutilized for such a purpose). The bottom shell 7 thus includes a recess7 a for such battery 8 placement with a bottom shell cover 9 provided toprotect and cover the battery 8 in much the same way the top shell cover1 provides such benefits for the processor 2. Thus, in FIG. 2 it isshown the total composite capnography device 10 with the aforementionedbreathing channel 12 to capture and measure carbon dioxide levels. Inthis manner, the patient (not illustrated) directs his or her expelledbreath through such a channel 12 in order for the carbon dioxide sensorcomponents 5 to detect such levels and record microvoltage changes inrelation to the concentration of carbon dioxide present within such achannel at any given time. The infrared beam generator 5 a supplies alaser to traverse the channel to the infrared sensor 5 b, therebyallowing for infrared beam distortions to be detected in relation tosuch carbon dioxide levels (and measured initially as, again,microvoltage levels that change due to infrared beam signal capture overtime). The battery 8 supplies sufficient power for the infrared beamgenerator 5 a to operate and the infrared sensor 5 b to record suchlevels. The battery 8 is connected with a switch (not illustrated)situated in proximity to the carbon dioxide sensor components 5 in orderto control activation and deactivation thereof as programmed within theprocessor 2. As the processor 2 sets the definitive program for suchseries of controls, the infrared beam generator 5 b can be controlledfor prolonged life in order to at least reduce the tendency forreplacement due to burn out, particularly since such infrared beamsrequire relatively high power for operation. To that end, such powerup/power down capabilities may be structured for cycles of anywhere from10 milliseconds to 10 seconds, if desired. The only limitation to suchcyclical activity being the ability provided through the processor 2 interms of its own speed for reaction times to compile and record theresults from such carbon dioxide level measurements. The processor 2further receives the microvoltage change measurements from the infraredsensor 5 b directly and compiles such results through a suitablealgorithm to generate a capnograph (not illustrated) that is thencompared with high and low limits of acceptable recorded carbon dioxiderespiratory levels. If the level is too low (indicating ineffectiveoxygen intake and/or ineffective respiration capabilities) or too high(indicating ineffective ability of the target patient to expire carbondioxide during respiration), the processor 2, subsequent to capnographgeneration, records and alerts the target patient (and any othercaregiver, selected associate to such patient, and the like) of such aresult. Such an alert may be provided immediately or in response tocontinued measurements within a certain time frame (for example, toohigh a level for such a specific target patient for more than 10 secondsor, with 10 millisecond cycles, for more than 75% of a 100 sequentialcycle series, again, of course, without limitation; the same may be trueand followed for too low a carbon dioxide measured level within thealgorithm of the processor 2, as well, again, though, withoutlimitation) such that even if a target patient has lost consciousness,the system utilizing the capnography device 10 provides constantsurveillance and monitoring to alert needed individuals and/or medicalprofessionals to provide immediate (or at least as soon as possible)attention. As discussed above, the processor 2 within the device 10allows for such instant compilation of data and alert capabilities ifneeded. The alert provision is permitted through the communicationplatform (radio, for example, without limitation, present in relation tothe processor 2) that sends to a base and/or data center (notillustrated) that sends to such individuals and/or medical professionalsas necessary (and as provided within the programmed system itself). Uponsuch alert, as noted above, the data center (not illustrated) includes aprocessor (not illustrated) with the same algorithm to compiletransferred data from the capnography device 10 in order to generate acapnograph readout on demand for further review and consideration by amedical professional. With the wireless capabilities provided by thedisclosed capnography device 10, comfort and versatility is provided forsuch respiration monitoring purposes that have heretofore beennonexistent within the medical field and other areas.

As alluded to above, the utilization of such a capnography device 10 maybe introduced within any type of system, overall device, environment,etc., that permits such constant surveillance and monitoring of aperson, patient, or both, in relation to the quality (and quantity, ifdesired) of his or her respiratory activity. Thus, this device 10 may beintroduced within a SCUBA system, an airplane pilot monitor, a militarysoldier monitor, a gas mask system, a firefighter mask system, an oxygenmask (or nares tubing device) system, and the like. FIGS. 3 and 4 showone possible embodiment of such an overall system with a CPAP mask 100including a capnography device 130 therein for patient monitoringpurposes. The CPAP mask 100 includes a mouth and nose cover 120 thathouses a remote, wireless capnography device 130. Such a capnographydevice 130 includes a channel 130 a aligned with the user's mouth andnose to receive expressed air (carbon dioxide, as one gas, of course)for measurement purposes. A hose 140 leads to the mouth and nose cover120 for supply of oxygen, as well. FIG. 4 shows the exploded view of thecapnography device 130 present within the mouth and nose cover 120 ofthe CPAP mask 100. In this iteration, there is present a top shell cover150 with a recess 150 a for the presence of the carbon dioxide sensorcomponents 200 (infrared beam generator 200 a and infrared sensor 200b). A bottom shell cover 500 is provide with a battery recess 500 a anda processor recess 500 b, as well as towers 500 c for carbon dioxidesensors 200 alignment (again they are opposite one another with achannel 130 a created by such towers 500 c). The processor 400 isprovided as above and the battery 300 as well. Again, cycles of power upand power down allows for generation and measurement of carbon dioxidelevels that are compiled by the processor 400 to allow for surveillanceand monitoring as needed with the same alert capabilities as describedabove, as well.

FIG. 5 shows a flow chart for one possible embodiment of the overallsystem directed to the capnography device components thereof. FIG. 6show a possible embodiment of the remainder of the overall system. Thesesteps include the cyclical method of collecting data pertaining to apatient/individual's respiratory status (carbon dioxide exhalationlevels) through initial power up of the infrared source and sensor bythe MCU 210 (also referred to as I1 for verification purposes),initializing the sensor to collect data from the IR beam 212, having anestablished instant with both beam and sensor in operation 213,collecting measurements in terms of the carbon dioxide “obstructions” ofthe IR beam (thus indicating concentration of carbon dioxide per voltagechanges at the IR sensor level) 214, filtering such measurements toproper levels 216, accumulating the collected data and transferringcontinuously to the MCU 218 (with the time such transfer begins as D1,and including the amount of data transferred, as well), determining ifmore data is needed within that cycle 220, particularly in response to alack of data transferred or if the amount transferred is below athreshold to meet a certain parameter for alarm generation purposes,where if more is needed (YES) then the system returns 222 to thesensor/beam establishment for continued measurements 213, (with anyfurther return potentially causing the device to determine a problemexists with the device or the patient/individual's respiratory status,thus necessitating alarm code generation) and then continuing throughthe steps 214, 216, 218, 220 until all such cycle data generation andcapture has occurred (220 N), providing a set amount of data transferredduring each cycle from the sensor to the MCU. At that point, the MCU maycompile the raw data through the algorithm to determine if carbondioxide parameters are met, exceeded, or too low for alarm purposes. Ifsuch parameters are not met for a set amount of time, then the MCU sendsthe necessary alarm code in relation to the parameter deficiency(ies) aswell as further raw data packets 224 to the base station, the datacenter, the patient, health care provider(s), monitoring individuals,emergency medical personnel, and/or selected individuals (familymembers, for example), wherein such alarms are communicated through anyor all of the available communication protocols present within thecapnography device, the base station, and/or the data center (thus,through RFID with an interrogation from the base station, throughwireless system, through Bluetooth, and/or through cellular platform).Such raw data packet transfers thus provides the unprocessed data to besent to different receivers for not only compilation and monitoring ofthe patient/individual's respiratory status subsequent to alarmgeneration of a problem situation, but also allows for such an algorithmat such different locations (again, such is the same algorithm in eachplace and instance) to verify such raw data is proper and reliable priorto such processing. The steps above 212 (D1), 214 (D1) provide specifictimes during each cycle that are pre-set prior to each cycle, thusallowing for the algorithm to check each data packet for such values. Ifany value is off, then the system determines a problem has occurred,whether in terms of sensor or IR source problems and/or defects, MCUproblems and/or defects, power switch problems and/or defects, and/orcompromised raw data (hacking). The presence of data that exceeds theset amount required during transfer from sensor to MCU indicates a hackhas most likely occurred, for instance. In such a situation, thealgorithm will not permit compilation of data and will prevent anyprocessing thereof, thus curtailing any potential threat to the softwareand/or hardware of the device and connected communication receiversassociated therewith. In any event, upon receipt by the MCU 220 N, suchraw data is initially compiled to determine the possible alarm statusfor the patient/individual. If the alarm does sound, as noted above,then such raw data is not only collected at the MCU but sent to theother devices for further verification overall that the raw data isreliable, but also to allow ultimately for the recipients tocontinuously monitor the patient/individual after the initialrespiratory status issue (alarm) has happened. With the initial MCUreceipt and compilation of raw data from the sensor, the algorithmtherein compiles such data in relation to the time initiated, the timetransferred from the sensor, the time such transfer is completed (withineach cycle), and the amount of data transferred within the timeframespecified, processing the data to create a continuous waveform forassessment of parameters of carbon dioxide levels, and notifying(through an alarm) if such measurements fall outside set maxima andminima, again, as alluded to above. Additionally, and as discussedabove, the overall system is provided with such specific raw data valuessuch that the mirrored algorithm (i.e., algorithm that is the samewithin each described device) utilized therein exhibits the capacity tocontinue searching for any missing raw data portion within a data packetprior to compilation and processing as such values as noted above mustbe filled within each data packet response prior to such action. Thus,unlike UDP protocols, which will ignore missing data and simply moveforward without such data present, leaving compromised data a distinctpossibility, at least, this system provides a manner of allowing forsimple search and locate of each data packet portion to ensurereliability overall prior to any processing of such raw data at anydevice.

FIG. 6 thus shows the method steps within the overall system undertakenat the base station, as one example, and as further discussed below.These steps include the initial power up of the station (or otherdevice, including the data center and smartphones, etc., of specifiedpre-set recipients of such information) 310 (again, with such anexternal location, considered as I1 for data verification purposes)which occurs automatically upon receipt of communication from the deviceMCU. At this point, there are two different pathways 312, 314 dependingon the manner of raw data transfer from the capnography device 224(either of which leads to receipt of transferred data considered as D1at such a location with the amount of data transferred as part of the D1value, as noted above). The first involves the wi-fi and/or Bluetoothand/or cellular communication alternative(s) 313 that receive suchtransferred raw data and move to an establishment point 330 in relationto further steps. The system at the base station (or other device) thendetermines if any requests for compilation by the algorithm have beenreceived from the capnography device 332. If not, then the systemreturns back 334 to the establishment point 330 to await anythingfurther subsequent to power up 310 and communication initiation 313. Ifthe request(s) is/are received 332 Y, then the system proceeds to acceptthe accumulated raw data from the MCU 336 and compile at the algorithmlevel to verify such data is true and to generate the continuouswaveform as data is received and authorized for processing. Once that isaccomplished, the response packet is sent to the data center 338 forfurther processing, as well as any other pre-selected recipient. Thesystem then returns 340 to the establishment point to await the nextdata packet transfer and to undertake the same steps again.Simultaneously, the base station undertakes initiation of the RFIDreader 316 to await response from an interrogation generated thereby andsent to the capnography device RFID tag. Upon establishing such has beeninitiated 318, the base determines if any requests of this type with rawdata from the capnography device have been received 320. If not, thenthe system returns 322 to the establishment point 318. If yes 320 Y,then the system appends such raw data to a reading buffer for algorithmsubmission and compilation as above. Once concluded, the system returns326 to the establishment point 318 to undertake the next submitted rawdata through this pathway 314. This further step is of utmost importancefor a number of reasons, including, without limitation, providing rawdata thereafter via any communication protocol present (RFID tag, wi-fi,Bluetooth, and/or cellular) to any or all of the base station, the datacenter, and selected recipients (doctor, relative, etc.) for furthermonitoring and waveform generation (with the algorithm used within thecapnography device MCU also present within each of such recipients'system for verified data transfer and reception and, upon verificationof reliable data transfer, processing thereof to create such acontinuous waveform) for further monitoring and surveillance unless anduntil such patient/individual is treated/rescued/etc. and suchcapnography system is not necessary any further. Thus, even though suchdata transfer from capnography device to base station may actually beprovided to the data center and other recipients (as noted above)directly from the capnography device itself, the system may also havethe initial transfer of raw data to the base station first and thentransferred to the data center, recipients, etc., thereafter (and may befrom data center to recipients or from base station to data center andrecipients simultaneously). Such raw data transfer and treatment atthese various locations is also, as noted previously, essential toensure the raw data itself is verified and completely reliable prior toprocessing by any processing component (whether at the base, the datacenter, or with any recipient's own device. Thus, the steps in FIG. 6may be considered as if such has occurred within the data center orsystems of such selected recipients separately or as well.

As an alternative device, then is the smart sensor capnography chip typeshown in relation to FIGS. 7 through 9. A ring chamber 400 (such as ahollow ring/tube for attachment within a intubating tube, as onenon-limiting example) is provided with a smart sensor miniaturized chip410 as described above (including the IR source and IR sensor component;not illustrated). FIG. 8 shows the separate (but connectable) housing420 including a connectivity component 422 (Bluetooth, Wi-Fi, cellularcomponents, at least), an RFID tag 424, an MCU components 426, and apower module 428. Additionally, the housing 420 including a basestructure 432 that holds a connection data chip 430 for storage of rawdata from the smart sensor chip (410 of FIG. 7) and transfer to the MCU426 for utilization thereof (determination of respiratory status forsurveillance and notification purposes, as described above). Thus, asconnected (such as snapped together, as one non-limiting possibility)the full capnography (smart sensor chip/housing) device 440 includes allsuch components with the smart sensor chip 410 aligned, if needed, withthe data storage chip 430. The ring chamber 400 thus provides the shapeand area to capture, momentarily, as needed, the targetpatient/individual's exhaled breath to provide a continuous and constantmeasure of carbon dioxide concentrations therein via the IRsource/sensor on/within the smart sensor capnography chip 410 whichtransfers to the data storage chip 430 which then transfers to the MCU426 for processing for alarm purposes, again, as noted above andthroughout, above. Thus, differently sized devices may function in sucha capacity for remote surveillance and notification possibilities in aconstant and continuous manner.

This overall system thus provides an overarching method for reliablycollecting carbon dioxide exhalation measurements through a wireless,remote device and monitoring continuously the levels generated andcaptured thereby for any abnormalities. With this wireless, remotecapability, comfort and safety are optimized with the ability to furtherprovide reliable raw data from the capnography device itself forsurveillance purposes, allowing for reliable notifications to beprovided to any selected recipients of any measurements that show excessor too low carbon dioxide emissions from the patient/individual, andfurther monitoring thereafter until proper treatment can be provided.This system removes the typical cumbersome wired monitoring devices thatare limited to hospital settings, allowing for such respiratorysurveillance capabilities in any setting that permits wirelesscommunications. The data integrity aspects of this overall system thusalso provide a reliability level prior to data processing that hasheretofore been nonexistent not only within the capnography art, but themedical field as well.

Having described the invention in detail it is obvious that one skilledin the art will be able to make variations and modifications theretowithout departing from the scope of the present invention. Accordingly,the scope of the present invention should be determined only by theclaims appended hereto.

I claim:
 1. A capnography monitoring, notification, and analysis systemfor an individual person comprising a) a capnography device having anexhalation capture passage, an infrared source providing an infraredbeam through said passage, an infrared sensor aligned opposite saidinfrared source to detect voltage variations associated with carbondioxide concentrations, inspiration length, and expiration length withinsaid individual's captured respiratory status, a microcomputer (MCU)programmed with a capnograph waveform generating algorithm, at least oneradio frequency identification (RFID) tag, an optional data storagecomponent other than said microcomputer, and a communication componentincluding a WIFI antenna, a blue-tooth antenna, and, optionally, acellular communicator, b) an external connectivity base comprising aninductive coupling component associated with said capnography device, areceiver component for reception of communicated information from saidcapnography device, a computer processor, and an information transfercomponent, wherein said external connectivity base computer processor isprogrammed with the same waveform generating algorithm as thecapnography device, and c) a data center comprising a rules engine, anda computer processor, wherein said data center computer processor isprogrammed with the same waveform generating algorithm as thecapnography device; wherein said algorithm programmed within saidcapnography device, said external connectivity base, and said datacenter compiles infrared sensor measurements from said infrared sensorto generate a capnograph waveform associated therewith, wherein said MCUof said capnography device further includes pre-set parametersassociated with certain maximum and minimum carbon dioxide measurementconcentrations, inspiration length measurement durations, and expirationlength measurement durations as captured by said infrared sensor andcompiled by said algorithm in a waveform, wherein if at any time duringutilization by said individual, said parameters are exceeded in terms ofsaid maximum or below said minimum carbon dioxide concentrations for apre-set continuous amount of time, then said microcomputer generates analarm for communication for immediate notification to pre-selectedparties as to the condition of said individual in relation to saidexhalation carbon dioxide concentration measurements, wherein, upon sucha notification action, said capnography device continues to capturecarbon dioxide exhalation concentration measurements with transfer fromsaid MCU in noncompiled state to at least one communication component ofsaid at least one RFID tag, Bluetooth antenna, WIFI antenna, and/orcellular communicator, for continuous transfer to either said externalconnectivity base thereafter and subsequently to said data center, or,alternatively, directly to said data center, and said MCU furthergenerates an alarm code within said capnograph waveform generatingalgorithm therein as an indicator of the situation pertaining to saidalarm generation, wherein said transfer to said external connectivitybase and/or said data center is undertaken for transfer of the alarmsituation whether in terms of patient/individual respiratory status orcapnography device status via compilation of said transferred raw datawithin said capnograph generating algorithm and verification andprocessing thereof; and wherein said capnography device further receivespower from and transfers information directly to said externalconnectivity base through said inductive coupling component uponplacement of said capnography device within a certain proximity theretosaid external connectivity base; wherein said inductive couplingcapability further provides raw data transfer and alarm notification tosaid external connectivity base upon discovery of defect within saidcapnography device for possible remedy thereof.
 2. The system of claim 1wherein said data transferred from said IR sensor to said capnographydevice MCU is provided through each data capture cycle in relation tothe time each cycle begins, the time said capnography device MCUreceives the data from said infrared sensor, and the amount of datatransferred from said infrared sensor to said capnography device MCU foran exact period of time, wherein such provided data is present within adata packet related to each data capture cycle with such specific valuesfor time and amount of data transferred included for verificationpurposes within said capnograph waveform generating algorithm, whereinif all of said values match the expected values at said data center foreach data packet therein received from said base, then said algorithmverifies such data packets are true and allows for further computerprocessing thereof to form said capnograph waveform for parametercomparisons of the status of said individual's respiratory status inorder to monitor for any excess or too low carbon dioxide levels,unacceptable inspiration duration, and/or unacceptable expirationduration, wherein if any parameters fall outside acceptable levels foran excessive time duration then said algorithm generates said alarmcode, wherein said alarm code causes certain activities within theoverall system to subsequently occur including: a) notification if suchdata indicates said individual requires immediate attention and/or saiddevice requires remedy for problems or defects therein, b) continuousstreaming of collected raw data from said IR sensor to said MCU topre-selected external locations that utilize the same capnographywaveform generating algorithm programmed within said capnography deviceMCU, and c) synching all of said programmed capnography waveformgenerating algorithms within said pre-selected external locations fordata reception, verification, and processing thereof to generate acontinuous waveform at each of said locations in relation to saidsubject individual's respiratory status; wherein such verificationprovides block chain capability within said system for completereliability of data.
 3. The system of claim 2 wherein said data capturecycles are undertaken within a first set time frame and, upon generationof an alarm and notification of carbon dioxide level issues, said datacapture cycle time frame is modified through a pre-set procedure withinsaid capnography device MCU with notification thereof to said externalconnectivity base and said data center in order to continue verificationprotocols for all such captured data and transfer of data packetsthereof transferred to said external locations.
 4. A wireless remotecapnography device comprising a three-dimensional housing, said housingincluding: a) a hollow pass-through chamber, b) at least onemicroprocessor (MCU) including an internal clock and programmed with analgorithm for translating raw data to a capnogram waveform, c) at leastone infrared (IR) source, d) at least one IR sensor, e) a component toreceive formatted data from the MCU and transfer received data to anexternal reader, said component being either i) a radio frequencyidentification tag (RFID) tag to transfer such data to an external RFIDreader imbedded in connectivity base, or ii) a near-field communication(NFC) tag and antennae to transfer such data to an external NFC reader;f) one or more communication devices for direct communication with saidexternal connectivity base and/or said external data center, saiddevices selected from the group consisting of wireless, Bluetooth,cellular, and any combinations thereof; g) a separate data storagedevice associated with an inductive coupling component; and h) at leastone power supply associated with said inductive coupling component;wherein said IR source and IR sensor are configured on opposing sides ofsaid pass-through chamber and aligned for emission of an IR beamdirectly towards said IR sensor; wherein said IR source is programmed toemit an IR beam within a range of from 4.26-4.30 mm frequency; whereinsaid microprocessor unit is connected to said IR sensor to permittransmission of data from said IR sensor to said microprocessor unit;wherein said microprocessor unit includes a flash memory component thatis formatted to receive said IR sensor-transmitted data; wherein saidmicroprocessor unit includes a program to format said IR-sensortransmitted data for proper transmission to produce proper capnographywaveform to and write on capability on said RFID tag or said NFC tag,and said device data storage chip; wherein said power supplycontinuously provides electrical power to said IR source, said IRsensor, and said MCU; wherein said power supply activates said IR sourceand said IR sensor upon activation through said MCU, or, permittransmission of power from said power supply to said IR source and saidIR sensor; wherein said IR sensor generates data from the emission beampassing through said open chamber from said IR source; wherein said datagenerated by said IR sensor automatically transmits to said MCU; whereinsaid MCU performs a regimen of activating and deactivating said IRsensor and said IR source at a set time interval in relation to said MCUinternal clock, thereby limiting the actual amount of data transmittedby and received from said IR sensor within each activation/deactivationcycle in order to thereafter and therein permit said MCU to store alltransferred information from said IR sensor within its flash memory;wherein said MCU is programmed to stop receipt of information from saidIR sensor and power down both said IR source and said IR sensor inevenly timed intervals, whereupon said MCU transfers said information todata storage chip; wherein said MCU is simultaneously and separatelyprogrammed to receive said data and generate a waveform therefromthrough utilization of said algorithm, thereby allowing for continuouscomparison with specified parameters of low and high thresholds ofcarbon dioxide levels for pre-set time intervals within said waveformassociated with said sensor results, wherein if such results falloutside said parameters, said MCU alerts proper individuals and/orentities of such an occurrence; wherein said MCU automatically formatsand transfers all received and stored information to said device datastorage chip as data packets for eventual transfer to said externalconnectivity base and then to said data center wherein the samealgorithm present within said MCU is utilized to generate a waveform forarchival and medical provider viewing purposes, said transfer providedthrough inductive coupling operation at the external connectivity basevia contact with said capnography device; wherein said RFID or NFC tagsends all received information from said MCU to said externalconnectivity base upon each interrogation and/or inductive coupling, or,if such a communication route is not possible, then the wireless,Bluetooth, or cellular communication device is utilized for such apurpose; wherein said suitable external connectivity base transfers allreceived information from said at least one RFID or NFC tag and/orwireless, Bluetooth, or cellular to said data center; wherein saidseparate storage device is programmed to receive information transferredfrom said MCU and subsequently transfer said information to saidexternal connectivity base through said inductive coupling component, ofwhich said external connectivity base includes a complementary componentsuch that contact therebetween allows for such information transfer;wherein said at least one power supply is replenishable through saidinductive coupling component and whereupon such contact therebetweensaid inductive coupling component and said complementary componentincluded within said external connectivity base device base stationallows for charging of said at least power supply; and wherein the totalsize of said housing, within which all of said components are attachedand present, is defined by a range of 3 to 10 centimeters wide, a rangeof 3 to 10 centimeters long, and from 3 to 10 centimeters deep.
 5. Thesystem of claim 3 wherein said verification activity within said datacenter includes a block chain result.
 6. A capnography monitoring,notification, and analysis system comprising a) the capnography deviceas in claim 4, wherein said device MCU is programmed with a capnographwaveform generating algorithm, b) an external connectivity basecomprising an inductive coupling component, a receiver component forreception of communicated information from said capnography device, acomputer processor, and an information transfer component, wherein saidexternal connectivity base computer processor is programmed with thesame waveform generating algorithm as the capnography device, and c) adata center comprising a rules engine, and a computer processor, whereinsaid data center computer processor is programmed with the same waveformgenerating algorithm as the capnography device; wherein said algorithmprogrammed within said capnography device, said external connectivitybase, and said data center compiles infrared sensor measurements fromsaid infrared sensor to generate a capnograph waveform associatedtherewith, wherein said MCU of said capnography device further includespre-set parameters associated with certain maximum and minimum carbondioxide measurement concentrations, inspiration length measurementdurations, and expiration length measurement durations as captured bysaid infrared sensor and compiled by said algorithm in a waveform,wherein if at any time during utilization by said individual, saidparameters are exceeded in terms of said maximum or below said minimumcarbon dioxide concentrations for a pre-set continuous amount of time,then said microcomputer generates an alarm for communication forimmediate notification to pre-selected parties as to the condition ofsaid individual in relation to said exhalation carbon dioxideconcentration measurements, wherein, upon such a notification action,said capnography device continues to capture carbon dioxide exhalationconcentration measurements with transfer from said MCU in noncompiledstate to at least one communication component of said at least one RFIDtag, Bluetooth antenna, WIFI antenna, and/or cellular communicator, forcontinuous transfer to either said external connectivity base thereafterand subsequently to said data center, or, alternatively, directly tosaid data center, and said MCU further generates an alarm code withinsaid capnograph waveform generating algorithm therein as an indicator ofthe situation pertaining to said alarm generation, wherein said transferto said external connectivity base and/or said data center is undertakenfor transfer of the alarm situation whether in terms ofpatient/individual respiratory status or capnography device status viacompilation of said transferred raw data within said capnographgenerating algorithm and verification and processing thereof; andwherein said capnography device further receives power from andtransfers information directly to said external connectivity basethrough said inductive coupling component upon placement of saidcapnography device within a certain proximity thereto said externalconnectivity base; wherein said inductive coupling capability furtherprovides raw data transfer and alarm notification to said base stationupon discovery of defect within said capnography device for possibleremedy thereof.
 7. The system of claim 6 wherein said data transferredfrom said IR sensor to said MCU is provided through each data capturecycle in relation to the time each cycle begins, the time the MCUreceives the data from said infrared sensor, and the amount of datatransferred from said infrared sensor to said MCU for an exact period oftime, wherein such provided data is present within a data packet relatedto each data capture cycle with such specific values for time and amountof data transferred included for verification purposes within saidalgorithm, wherein if all of said values match the expected values atsaid data for each data packet therein received from said base, thensaid algorithm verifies such data packets are true and allows forfurther computer processing thereof to form said capnograph waveform forparameter comparisons of the status of said individual's respiratorystatus in order to monitor for any excess or too low carbon dioxidelevels, unacceptable inspiration duration, and/or unacceptableexpiration duration, wherein if any parameters fall outside acceptablelevels for an excessive time duration then said algorithm generates saidalarm code, wherein said alarm code causes certain activities within theoverall system to subsequently occur including: a) notification if suchdata indicates said individual requires immediate attention and/or saiddevice requires remedy for problems or defects therein, b) continuousstreaming of collected raw data from said IR sensor to said MCU topre-selected external locations that utilize the capnograph waveformgenerating algorithm of said MCU, and c) synching all of said capnographwaveform generating algorithms within said pre-selected externallocations for data reception, verification, and processing thereof togenerate a continuous waveform at each of said locations in relation tosaid subject individual's respiratory status; wherein such verificationprovides block chain capability within said system for completereliability of data.
 8. The system of claim 7 wherein said data capturecycles are undertaken within a first set time frame and, upon generationof an alarm and notification of carbon dioxide level issues, said datacapture cycle time frame is modified through a pre-set procedure withinsaid MCU with notification thereof to said external connectivity baseand said data center in order to continue verification protocols for allsuch captured data and transfer of data packets thereof.
 9. The systemof claim 8 wherein said verification activity within said data centerincludes a block chain result.